Kornimate/medical-research-clean huggingface dataset:
hepatic histopathology in urea cycle disorders

Conditions: Urea Cycle Disorder; Ornithine Transcarbamylase Deficiency; Citrullinemia 1; ARGI Deficiency; ASL Deficiency; Argininosuccinic Aciduria; ASS Deficiency; Hyperargininemia; Carbamyl Phosphate Synthetase Deficiency; NAGS Deficiency

Summary: this is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any ucd diagnosis. this study will be conducted at all urea cycle disorders consortium (ucdc) sites: baylor college of medicine in houston, tx and children's national medical center in washington d.c.

urea cycle disorders (ucds) are among the most common inborn errors of liver metabolism. with early diagnosis and improved treatments, the survival of individuals with ucds has improved, and this improved survival has led to unmasking of some long-term complications such as hepatic dysfunction and progressive fibrosis in a subset of patients. hepatic complications in ucds are quite variable and dependent upon the specific metabolic defect.

Eligibility criteria:
inclusion criteria: * diagnosis of primary urea cycle disorder based on clinical suspicion confirmed by enzyme activity, dna testing or metabolite analysis. * history of liver transplantation and/or liver biopsy or * planned liver transplantation and/or liver biopsy exclusion criteria: * unavailability of histopathology report from the liver biopsy or explant, or unavailability of liver tissue or slides from the biopsy or explant or * anticipated inability to obtain pathology report, liver disease, tissue blocks, or pathology slides after liver biopsy or transplantation * known history of a secondary cause for liver disease such as chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, or tpn-related cholestatic disease

Keywords: liver transplant liver disease liver biopsy histopathology
study of emerfetamab (amg 673) in adults with relapsed/refractory acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: the primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (aml) and to estimate the maximum tolerated dose (mtd) and/or a biologically active dose (eg, recommended phase 2 dose \[rp2d\]).

this is a first-in-human, open-label, phase 1, sequential dose escalation study. emerfetamab will be evaluated as a short term intravenous (iv) infusion in adults with relapsed/refractory aml the study will consist of a dose escalation phase and a dose expansion phase. the study was terminated prior to the start of the expansion phase.

Eligibility criteria:
inclusion criteria * subject has provided informed consent prior to initiation of any study-specific activities/procedures. * subjects ≥ 18 years of age at the time of signing consent. * aml as defined by the world health organisation (who) classification persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (apml). * more than 5% myeloblasts in bone marrow. * eastern cooperative oncology group (ecog) performance status of ≤ 2. exclusion criteria * known hypersensitivity to immunoglobulins. * autologous hematopoietic stem cell transplantation (hsct) within 6 weeks prior to start of amg 673 treatment. * allogeneic hsct within 3 months prior to start of amg 673 treatment. * non-manageable graft versus host disease. * known positive test for human immunodeficiency virus (hiv). * males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 15 weeks after receiving the last dose of study drug. acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (iud) (women). males who are unwilling to abstain from sperm donation while on study through 5 half-lives after receiving the (last \[multiple-dose studies\]) dose of study drug. * females who are lactating/breastfeeding or who plan to breastfeed while on study through 15 weeks after receiving the last dose of study drug. * females with a positive pregnancy test * females planning to become pregnant while on study through 15 weeks after receiving the last dose of study drug.
safety and efficacy of brm421 for dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the objective of this study is to compare the safety and efficacy of brm421 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye.

this is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a reported history of dry eye for at least 6 months prior to enrollment; * have a history of use of eye drops exclusion criteria: * have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception
erdosteine (erdotin) versus standard care plus placebo on erdosteine for treatment of cough in acute exacerbations of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial. 60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of chronic obstructive pulmonary disease (copd). acute exacerbation of copd will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication. the primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (day 0) and at day 5 of treatment, compared with standard care plus placebo.


Eligibility criteria:
inclusion criteria: * male/females aged between 40-80 years * previous diagnosis of copd * acute exacerbation of copd requiring treatment with antibiotics and/or corticosteroids * symptoms of increased breathlessness, cough, sputum volume or sputum purulence * acute exacerbation of copd hospitalised within 24hrs of study participation. * on a stable therapeutic regimen for copd for 8 weeks prior to inclusion * known history of cigarette smoking at least 10 pack yrs * willing and able to comply with study procedures * able to provide written informed consent to participate exclusion criteria: * acute exacerbation of copd within 8 weeks prior to inclusion * arterial blood gas on admission \< ph 7.26 * currently on treatment with mucolytics * patients suffering from post nasal drip, or gastro-oesophageal reflux disease * clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus * on long-term oxygen therapy * known or suspected hypersensitivity to erdosteine

Keywords: cough exacerbation quality of life
observational study with mixtard® 30 novolet® to assess patient satisfaction

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the novolet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.


Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or type 2) * patient not presently using mixtard® 30 novolet®
web-based international register of emergency surgery and trauma

Conditions: Acute Appendicitis; Acute Cholecystitis; Acute Diverticulitis; Post-operative Complications; Acute Pancreatitis; Perforated Gastro-duodenal Ulcers; Adhesive Small Bowell Occlusion; Colonic Neoplastic Emergencies; Gynecological Emergencies; Vascular Emergencies; Intestinal Ischemia; Abdominal Wall Hernia; Foreign Bodies; Caustic Ingestion; Trauma

Summary: the wires-t project (web-based international registry of emergency general surgery and trauma) has been set up to allow to all the egs (emergency general surgery) and trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. this will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.


Eligibility criteria:
inclusion criteria: * patients affected by an acute surgical disease * patients with indication to be referred to the emergency surgeon attention * patients to be operated or to be treated with non-operative approach without surgical intervention exclusion criteria: * patients not affected by an acute surgical disease * patients without indication to be referred to the emergency surgeon attention
study to evaluate the efficacy and safety of intravitreal otx-tki (axitinib implant) in subjects with neovascular age- related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: study to evaluate the efficacy and safety of intravitreal otx-tki (axitinib implant) in subjects with neovascular age- related macular degeneration


Eligibility criteria:
inclusion criteria: * treatment naïve juxtafoveal and/or sfnv secondary to neovascular age- related macular degeneration (namd) with leakage involving the fovea in the study eye prior to screening, or have a diagnosis of neovascular age- related macular degeneration (namd) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to screening * have provided written consent exclusion criteria: * monocular subject or best corrected visual acuity (bcva) score of \<20 etdrs letters or 20/400 in fellow eye at screening * have evidence of a scar, fibrosis, or atrophy of \>50% of the total lesion in the study eye.

Keywords: neovascular age-related macular degeneration tyrosine kinase inhibitor otx-tki
activity to improve outcomes in peripheral arterial disease

Conditions: Peripheral Arterial Occlusive Disease

Summary: peripheral artery disease (pad) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. this may cause difficulty or pain with walking or other activities that use leg muscles. exercise may help improve blood flow in the legs and improve the ability to walk. this research project is being implemented in adults with pad to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

this pilot study seeks to gather data on different exercise interventions in pad. collectively, the proposed studies will gather data on the role of novel exercise interventions in those with pad who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease. we hypothesize that patients who undergo an exercise intervention will: a) show improved lower extremity perfusion and b) improve their functional ability, compared to a standard care control group over 6 months of follow-up. we further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

Eligibility criteria:
inclusion criteria: * age 21-90 years * ankle brachial index \< 0.9 exclusion criteria: * cancer under active treatment, except prostate, skin, and hematologic cancers * planned for open lower extremity bypass surgery * body mass index \>45 * lower extremity gangrene

Keywords: peripheral arterial disease endovascular exercise perfusion functional capacity
assessment of the effects of tegaserod in the management of gastroesophageal reflux disease (gerd) in patients with incomplete response to proton pump inhibitors (ppis).

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: study to assess the effects of adding tegaserod to ppi therapy results in clinically meaningful improvement of gerd symptoms in patients with incomplete relief of symptoms on daily ppi therapy alone.


Eligibility criteria:
inclusion criteria: * gerd symptoms for at least 6 months * ppi therapy for at least 4 weeks * incomplete symptom relief on daily ppi therapy * no erosive disease as evidenced in egd/no change in symptom severity exclusion criteria: * evidence of structural abnormality of the gastrointestinal tract or disease/conditions * previous gastrointestinal surgery that may influence esophageal motor function * known primary esophageal motor disorder other than inefficient esophageal motor disorder * evidence of cathartic colon or a history of laxative use other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gerd ppi
buprenorphine stabilization and induction onto vivitrol for heroin-dependent individuals

Conditions: Heroin Dependence

Summary: a short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto vivitrol.


Eligibility criteria:
inclusion criteria: 1. individuals between the ages of 18-60 2. meets dsm-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin 3. seeking treatment for opioid use disorder with vivitrol 4. capable of giving informed consent and complying with study procedures 5. in otherwise good health based on complete medical history and physical examination, laboratory tests, and ekg 6. bmi between 18-40 exclusion criteria: 1. reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent 2. maintenance on, or regular use of buprenorphine or other prescription opioids 3. pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 4. active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with ast or alt \> 3 times normal, aids (cd4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease. 5. active psychiatric disorder which might interfere with participation or make participation hazardous, including dsm-5 schizophrenia or any psychotic disorder, severe major depressive disorder, or suicide risk or 1 or more suicide attempts within the past year. 6. physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. other substance use diagnoses are not exclusionary. 7. history of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam. 8. chronic neurocognitive disorder 9. history of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received. 10. painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications 11. fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids. 12. court mandated to treatment
effect of transcranial direct current stimulation (tdcs) and probiotic supplementation in overweight adults

Conditions: Overweight and Obesity

Summary: the aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tdcs stimulation on risky decision-making related to food choices in overweight people. considering the relatively established communication and interaction between the gut-brain-microbiome axis, the investigators expect that transcranial direct current stimulation and probiotic supplementation can both improve decision-making (decrease risky and impulsive decisions) and increase self-control in overweight people.


Eligibility criteria:
inclusion criteria: * bmi over 25 * higher than normal fat level exclusion criteria: * pregnancy * breastfeeding * smoking more than 10 cigarettes a day * excessive consumption of alcohol * suffering from chronic cardiovascular and kidney diseases * chronic digestive diseases such as celiac disease, * chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc. * suffering from acute and chronic diarrhea in the last one month * taking antibiotics in two months before the start of the study, * continuous use of prebiotic and probiotic products and drugs in one month before the start of the intervention * frequent use of antibiotics during the last month before the start of the intervention * taking weight loss medications and following a special slimming diet in the last 3 months before the intervention. * history of epilepsy and seizures, stroke, * use of pacemaker * presence of metal implanted in the scalp or brain, * presence of skin lesions at the tdcs stimulation site, and history of head injury or brain surgery. * brain disorders and long-term and chronic use of neuropsychiatric drugs.

Keywords: transcranial direct current stimulation obesity overweight impulse control
perl continuous glucose monitoring (cgm) study

Conditions: Diabetic Nephropathies

Summary: seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. however, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. the perl trial (nct02017171), testing whether treatment with allopurinol can slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess the role of glycemic variability in the progression of diabetic kidney disease in individuals who already have mild to moderate kidney disease. by applying continuous glucose monitoring (cgm) in the perl study population, the investigators will be able to better understand how metrics of glycemia (mean, time above and below range, and various measures of variability) are associated with renal outcomes in the perl population as a whole, but also in important subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing gfr decline, allopurinol vs. placebo arms). the nvestigators also aim to obtain precise information on the range of blood glucose corresponding to any given hba1c value in this population since previous studies generally excluded patients with renal disease.

participants who consent to the study will have an abbott freestyle libre pro sensor placed on the back of their upper arm at their first perl visit after this ancillary study has begun and at all subsequent perl visits. the sensor will be continuously worn by participants for 14 days. at the end of the 14 days, the sensor will be removed and mailed by the participant to the coordinating center. since subjects are at various stages of the perl protocol, the number of remaining visits at which the cgm will be applied will vary among subjects. study aims 1. to assess the effect of glycemic variability, as measured by the coefficient of variation of cgm glucose (cv, the ratio of standard deviation and the mean of cgm glucose values), on the perl renal functional endpoint (iohexol gfr at the end of study). 2. to assess the effect of other glycemic parameters measured by cgm (mean glucose, % time 70-180 mg/dl, % time below 54 mg/dl, % time below 70 mg/dl, % time above 180 mg/dl, % time above 250 mg/dl, mean amplitude of glucose excursions \[mage\], low blood glucose index \[lbgi\], high blood glucose index \[hbgi\]) on the perl renal functional endpoint. 3. to assess the relationship between cgm-measured glycemic parameters and hba1c at various levels of renal function. 4. to compare the effects of cgm metrics on the perl renal endpoint and the corresponding effect of hba1c. 5. to assess the effect of allopurinol treatment on all of the different glycemic metrics including hba1c, cv, etc. and on their association with the perl renal endpoint.

Eligibility criteria:
inclusion criteria: • being an active participant in the perl clinical trial exclusion criteria: * having completed perl visit 16 * pregnancy * history of skin reactions in relation to the application of abbott freestyle libre pro
a study of an experimental chemotherapy combination to treat hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to determine whether ly2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable * hormone refractory prostate cancer defined as progressive based by documented 2 increase prostate specific antigen (psa) values over a previous reference value. * eastern cooperative oncology group (ecog) status 0-2 * adequate hematological functions, liver and renal functions exclusion criteria: * known hypersensitivity to docetaxel or taxane therapy * documented central nervous system or leptomeningeal metastasis at time of study entry * had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area. * evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary. * have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.

Keywords: hormone refractory prostate cancer